Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000454471
Ethics application status
Approved
Date submitted
3/09/2007
Date registered
10/09/2007
Date last updated
27/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of peripheral visual acuity and central and peripheral contrast sensitivity measures
Scientific title
A prospective multiple group study to develop a repeatable new computer-based test for measuring peripheral visual acuity and central and peripheral contrast sensitivity in emmetropic and myopic children, adolescents and adults.
Universal Trial Number (UTN)
Trial acronym
PVACS - peripheral visual acuity and contrast sensitivity
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal central and peripheral visual fielding terms of visual acuity and contrast sensitivity. 2324 0
Condition category
Condition code
Eye 2425 2425 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement of peripheral visual acuity and central and peripheral contrast sensitivity using a new computer-based test. Peripheral measures will be made at a viewing angle of 30 degrees in both nasal and temporal visual fields. Measures will be made on three separate days, consecutive if possible, to assess repeatability,
Intervention code [1] 2042 0
Diagnosis / Prognosis
Comparator / control treatment
There is no control group or treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3324 0
Repeatability of peripheral visual acuity, peripheral contrast sensitivity and central contrast sensitivity measures in a normal population.
Timepoint [1] 3324 0
Repeatability measures will be made on three separate occasions, preferably on consecutive days.
Secondary outcome [1] 5535 0
Peripheral visual acuity in myopic versus emmetropic participants and peripheral contrast sensitivity in myopic versus emmetropic participants.
Timepoint [1] 5535 0
Measures will be made on three separate occasions, preferably on consecutive days, in each group and the average value compared.

Eligibility
Key inclusion criteria
1) be between 6 and 40 years of age.
2) have ocular health findings considered to be “normal”.
3) have central vision correctable to at least 6/9 (20/30) or better in each eye.
4) have emmetropia or myopia comprising spectacle or contact lens wearers.
Minimum age
6 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) have had intraocular eye surgery.
2) have undergone corneal surgery.
3) have had extraocular surgery within 12 weeks immediately prior to enrolment for this trial.
4) be undergoing orthokeratology, or had orthokeratology within 3 weeks immediately prior to enrolment for this trial.
5) have any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
6) have strabismus or amblyopia.
7) have any disorder of the retina or visual pathways.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2584 0
Other
Name [1] 2584 0
Institute for Eye Research
Country [1] 2584 0
Australia
Funding source category [2] 2607 0
Other
Name [2] 2607 0
Institute for Eye Research
Country [2] 2607 0
Australia
Primary sponsor type
Other
Name
Institute for Eye Research
Address
University of New South Wales
Rupert Myers Building
Gate 14 Barker St
Level 4 North Wing
Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 2336 0
Other
Name [1] 2336 0
Institute for Eye Research
Address [1] 2336 0
University of New South Wales
Rupert Myers Building
Gate 14 Barker St
Level 4 North Wing
Kensington NSW 2033
Country [1] 2336 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28025 0
Address 28025 0
Country 28025 0
Phone 28025 0
Fax 28025 0
Email 28025 0
Contact person for public queries
Name 11182 0
Andrew Whatham
Address 11182 0
Institute for Eye Research
Level 3 Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Sydney NSW 2052
Country 11182 0
Australia
Phone 11182 0
+61 2 93857542
Fax 11182 0
Email 11182 0
A.Whatham@ier.org.au
Contact person for scientific queries
Name 2110 0
Andrew Whatham
Address 2110 0
Institute for Eye Research
Level 3 Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Sydney NSW 2052
Country 2110 0
Australia
Phone 2110 0
+61 2 93857542
Fax 2110 0
Email 2110 0
A.Whatham@ier.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.